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AstraZeneca Touts New Tagrisso Data

[ Price : $8.95]

AstraZeneca says new study data on Tagrisso (osimertinib) show an improved overall survival trend in certain patients with non-sma...

Exer Labs Illegally Marketing Exer Scan: FDA

[ Price : $8.95]

FDA warns Denver, CO-based Exer Labs about illegally marketing its Exer Scan device that has Quality System Regulation violations.

Essure Issues Web Page Updated

[ Price : $8.95]

FDA says it received 803 medical device reports on Bayers withdrawn Essure birth control implant in 2024, the lowest number since ...

Maintain, Apply Tabloid Guidance: Petition

[ Price : $8.95]

A Buchanan Ingersoll & Rooney petition asks FDA to continue the product-specific guidance restrictions on ANDAs citing Waylis canc...

Lytgobi Web Page False, Misleading: FDA

[ Price : $8.95]

The CDER Office of Prescription Drug Promotion cautions Taiho Oncology about misleading efficacy presentations in a Web page for i...

Approvable Letter for Sleep Apnea Device

[ Price : $8.95]

FDA sends Nyxoah an approvable letter on its PMA for the Genio system, a neuromodulation device for treating obstructive sleep apn...

Rybrevant Beats Tagrisso in Head-to-Head Trial: J&J

[ Price : $8.95]

Johnson & Johnson says Rybrevant outperformed AstraZenecas Tagrisso in a head-to-head study in the first-line treatment of patient...

Covidien Recalls Shiley Tracheostomy Tube

[ Price : $8.95]

Covidien recalls its Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula due to safety concerns if...

7 QS Violations in Dexcom Inspection

[ Price : $8.95]

FDA warns San Diego-based Dexcom about Quality System violations in its production of unapproved glucose monitors.

API Deviations at Aspen Biopharma Labs

[ Price : $8.95]

FDA warns Indias Aspen Biopharma about CGMP deviations in its manufacturing of active pharmaceutical ingredients.